Teva North America

12 recalls •

💊 Drugs

• Categories: Prescription Drugs

Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86

Class I - Dangerous

Failed Impurities/Degradation Specifications.

Aug 5, 2016 Prescription Drugs Nationwide View Details →

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

Class I - Dangerous

Superpotent drug: Out of specification test result for assay during stability testing.

Jun 24, 2016 Prescription Drugs Nationwide View Details →

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

Class I - Dangerous

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

Jun 22, 2016 Prescription Drugs Nationwide View Details →

Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.

Class I - Dangerous

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Jul 15, 2016 Prescription Drugs Nationwide View Details →

Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.

Class I - Dangerous

Failed Tablet/Capsule Specifications

May 18, 2016 Prescription Drugs Nationwide View Details →

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

May 31, 2016 Prescription Drugs Nationwide View Details →

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

Class I - Dangerous

Lack of Assurance of Sterility: Due to potential for leaking bags.

Apr 27, 2016 Prescription Drugs Nationwide View Details →

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89

Class I - Dangerous

Failed Dissolution Specifications: low test results at the 18 month time-point

Dec 21, 2015 Prescription Drugs Nationwide View Details →